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NCT Number: NCT07748026

A Study of ART105 in Healthy Adult Participants

The goal of this clinical trial is to learn if ART105 is safe in healthy adult participants. It will also learn about the PK and PD profiles of ART105. The main questions it aims to answer are:

Is ART105 safe and tolerable in adult participants? How does the ART105 influence the urine PC1 level of participants?

Participants will:

recieve single dose of ART105 and visit the clinic 3 months

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Key information

Conditions

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Voluntary participation with signed written informed consent (ICF) .
  • Male or female, aged 18-55 years (inclusive).
  • males ≥ 50 kg; females ≥ 45 kg; and BMI between 19 and 26 kg/m² (inclusive).
  • No history of clinically significant abnormalities.
  • Normal or not clinically significant (NCS) findings at screening for vital signs, physical exam, lab tests, 12-lead ECG, and abdominal ultrasound.
  • Participants of childbearing potential (or males with partners of childbearing potential) must agree to use highly effective contraception.

Exclusion criteria

  • Any uncontrolled or severe disease, or any medical or surgical condition that may interfere with the participant's participation in the clinical trial
  • History of hypersensitivity to oligonucleotide drugs, or known hypersensitivity to the investigational product or any of its excipients
  • Use of any ASO or siRNA drugs within 12 months prior to the first dose
  • History of alcohol abuse
  • History of drug or substance abuse, or a positive urine drug abuse screening test
  • Major surgery within 3 months prior to the administration of the investigational product or planned elective surgery during the study period.
  • Use of any prescription medications, over-the-counter (OTC) drugs, or herbal medicines within 14 days prior to the administration of the investigational product, or within 5 half-lives of the drug (whichever is longer).
  • Enrollment in or ongoing participation in any other clinical trial within 3 months or 5 half-lives (whichever is longer) prior to the administration of the investigational product
  • Positive screening results for hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (anti-HCV), human immunodeficiency virus antibody (anti-HIV), or Treponema pallidum antibody (syphilis).
  • Occurrence of acute illness or use of concomitant medications from the screening phase until prior to the administration of the investigational product.
  • Consumption of any alcohol-containing products or a positive breath alcohol test within 48 hours prior to the administration of the investigational product.
  • Participants who, in the investigator's opinion, have other factors that make them unsuitable for participation in this study.

Treatment and study plan

ART105

Drug

injection

Placebo

Drug

injection

Primary outcomes

  1. Incidence of AEs

    Time frame: Baseline to Day 85

    Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)

Secondary outcomes

  1. Plasma maximum observed concentration (Cmax) of ART105

    Time frame: Baseline to Day 3

  2. Plasma time to maximum observed concentration (Tmax) of ART105

    Time frame: Baseline to Day 3

  3. Plasma half-life (t½) of ART105

    Time frame: Baseline to Day 3

  4. Plasma area under the concentration-time curve up to 24 hr post dose (AUC0-24) of ART105

    Time frame: Baseline to Day 3

  5. Fraction of ART105 excreted in the urine (fe)

    Time frame: Baseline to Day 3

  6. Total amount of ART105 excreted in the urine (Ae)

    Time frame: Baseline to Day 3

  7. PD biomarkers change

    Time frame: Baseline to Day 85

    Changes from baseline in urine PC1 and PC2 levels

Other outcomes

  1. Concentration of neutrophil gelatinase-associated lipocalin (NGAL) in urine

    Time frame: Baseline to Day 29

  2. Concentration of kidney injury molecule-1 (KIM-1) in urine

    Time frame: Baseline to Day 29

  3. Incidence of ADA

    Time frame: Baseline to Day 85

    Incidence of ADA with NAb testing for ADA-positive samples if necessary

Sponsors and collaborators

Lead sponsor

Arnatar Therapeutics, Inc.

Industry

Registry information

Official study title

A Phase I, Randomized, Double-blind, Placebo-controlled, Dose-escalation Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of a Single Subcutaneous Injection of ART105 in Healthy Adult Participants

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Aug 5, 2026
Registry last updated
Aug 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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